Data / Drug companies / Biguanide
Biguanide drugs: 27 drugs from 103 companies in the FDA NDC directory
Biguanide is an FDA established pharmacologic class. The FDA National Drug Code Directory lists 630 products in this class from 103 companies, covering 27 drugs by generic name. The main marketing category is generic drugs (ANDA), and the newest product started marketing on October 25, 2026.
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- 103Companies
- 630Products
- 27Drugs by generic name
Drugs in the Biguanide class
Ranked by number of companies that list the drug.
Companies with the most products in this class
| Company | Products | Main dosage forms | Main marketing category | Newest product started |
|---|---|---|---|---|
| A-S Medication Solutions | 66 | tablet, film coated; tablet | Generic drugs (ANDA) | August 25, 2025 |
| Bryant Ranch Prepack | 30 | tablet, extended release; tablet | Generic drugs (ANDA) | May 1, 2024 |
| Aphena Pharma Solutions - Tennessee, LLC | 22 | tablet, extended release; tablet | Generic drugs (ANDA) | June 11, 2024 |
| Remedyrepack Inc. | 20 | tablet, extended release; tablet, film coated | Generic drugs (ANDA) | October 25, 2026 |
| Preferred Pharmaceuticals Inc. | 19 | tablet; tablet, film coated | Generic drugs (ANDA) | August 27, 2026 |
| NuCare Pharmaceuticals,Inc. | 18 | tablet; tablet, film coated | Generic drugs (ANDA) | August 25, 2025 |
| Boehringer Ingelheim Pharmaceuticals, Inc. | 17 | tablet, extended release; tablet | New drug applications (NDA) | April 23, 2020 |
| Ascend Laboratories, LLC | 16 | tablet, film coated; tablet, film coated, extended release | Generic drugs (ANDA) | April 6, 2026 |
| PD-Rx Pharmaceuticals, Inc. | 15 | tablet, extended release; tablet | Generic drugs (ANDA) | August 25, 2025 |
| Proficient Rx LP | 14 | tablet, film coated; tablet | Generic drugs (ANDA) | June 26, 2019 |
| Macleods Pharmaceuticals Limited | 12 | tablet, extended release; tablet, film coated | Generic drugs (ANDA) | April 6, 2026 |
| Aurobindo Pharma Limited | 11 | tablet, extended release; tablet, film coated, extended release | Generic drugs (ANDA) | April 6, 2026 |
| Zydus Lifesciences Limited | 11 | tablet, film coated; tablet | Generic drugs (ANDA) | May 5, 2016 |
| Northwind Health Company, LLC | 10 | tablet, extended release; tablet, film coated | Generic drugs (ANDA) | December 30, 2025 |
| Zydus Lifesciences Limited | 10 | tablet, film coated, extended release; tablet, film coated | New drug applications (NDA) | October 31, 2024 |
| Zydus Pharmaceuticals USA Inc. | 10 | tablet, film coated, extended release; tablet, film coated | New drug applications (NDA) | October 31, 2024 |
| Coupler LLC | 9 | tablet, extended release; tablet | Generic drugs (ANDA) | June 16, 2026 |
| Heritage Pharmaceuticals Inc. D/B/A Avet Pharmaceuticals Inc. | 9 | tablet; tablet, film coated | Generic drugs (ANDA) | May 1, 2024 |
| Merck Sharp & Dohme LLC | 9 | tablet, film coated; tablet, film coated, extended release | New drug applications (NDA) | December 19, 2017 |
| ScieGen Pharmaceuticals, Inc. | 9 | tablet; tablet, film coated, extended release | Generic drugs (ANDA) | August 21, 2026 |
| Zydus Pharmaceuticals USA Inc. | 9 | tablet, film coated; tablet | Generic drugs (ANDA) | May 5, 2016 |
| Aurobindo Pharma Limited | 8 | tablet, film coated | Generic drugs (ANDA) | February 13, 2013 |
| Chartwell RX, LLC | 8 | tablet; tablet, film coated | Generic drugs (ANDA) | June 29, 2010 |
| Direct_Rx | 8 | tablet; tablet, extended release | Generic drugs (ANDA) | January 29, 2026 |
| Janssen Pharmaceuticals, Inc. | 8 | tablet, film coated; tablet, film coated, extended release | New drug applications (NDA) | September 20, 2016 |
| Mylan Pharmaceuticals Inc. | 8 | tablet, film coated, extended release; tablet, film coated | Generic drugs (ANDA) | August 8, 2023 |
| Quallent Pharmaceuticals Health LLC | 8 | tablet; tablet, film coated | Generic drugs (ANDA) | December 15, 2025 |
| Westminster Pharmaceuticals, LLC | 8 | tablet, film coated; tablet, coated | Generic drugs (ANDA) | October 23, 2025 |
| Epic Pharma, LLC | 7 | tablet, film coated; tablet, extended release | Generic drugs (ANDA) | July 8, 2020 |
| Granules India Limited | 7 | tablet; tablet, extended release | Generic drugs (ANDA) | February 1, 2021 |
| Granules Pharmaceuticals Inc. | 7 | tablet, extended release; tablet | Generic drugs (ANDA) | January 22, 2021 |
| Micro Labs Limited | 7 | tablet, film coated, extended release; solution | Generic drugs (ANDA) | October 1, 2026 |
| Novadoz Pharmaceuticals LLC | 7 | tablet, film coated, extended release; tablet, film coated | Generic drugs (ANDA) | April 6, 2026 |
| Bryant Ranch Prepack | 6 | tablet; tablet, extended release | Generic drugs (ANDA) | August 6, 2020 |
| Bryant Ranch Prepack | 6 | tablet; tablet, extended release | Generic drugs (ANDA) | August 6, 2020 |
| AstraZeneca Pharmaceuticals LP | 5 | tablet, film coated, extended release | New drug applications (NDA) | October 29, 2014 |
| Golden State Medical Supply, Inc. | 5 | tablet, film coated, extended release; tablet, film coated | Generic drugs (ANDA) | April 30, 2026 |
| Laurus Labs Limited | 5 | tablet, film coated; tablet, extended release | Generic drugs (ANDA) | October 6, 2023 |
| Marksans Pharma Limited | 5 | tablet, film coated; tablet, extended release | Generic drugs (ANDA) | May 12, 2016 |
| NCS HealthCare of Ky, LLC DBA Vangard Labs | 5 | tablet, film coated; tablet, extended release | Generic drugs (ANDA) | March 29, 2024 |
| Precision Dose, Inc. | 5 | tablet, coated; tablet, extended release | Generic drugs (ANDA) | February 15, 2024 |
| QPharma, Inc. | 5 | tablet; tablet, film coated | Generic drugs (ANDA) | August 25, 2025 |
| Rising Pharma Holdings, Inc. | 5 | tablet, film coated | Generic drugs (ANDA) | February 13, 2013 |
| Time Cap Laboratories, Inc | 5 | tablet, film coated; tablet, extended release | Generic drugs (ANDA) | November 14, 2016 |
| Ajanta Pharma USA Inc. | 4 | tablet, extended release | Generic drugs (ANDA) | March 9, 2021 |
| AvKARE | 4 | tablet, extended release; tablet, film coated | Generic drugs (ANDA) | June 11, 2024 |
| Legacy Pharmaceutical Packaging, LLC | 4 | tablet; tablet, extended release | Generic drugs (ANDA) | March 10, 2022 |
| Lupin Pharmaceuticals, Inc. | 4 | tablet, extended release | Generic drugs (ANDA) | April 17, 2026 |
| Lupin Pharmaceuticals, Inc. | 4 | tablet, extended release | Generic drugs (ANDA) | February 1, 2016 |
| Proficient Rx LP | 4 | tablet, extended release; tablet, film coated | Generic drugs (ANDA) | August 25, 2025 |
| Aci Healthcare USA, Inc. | 3 | tablet | Generic drugs (ANDA) | January 15, 2018 |
| American Health Packaging | 3 | tablet, film coated | Generic drugs (ANDA) | April 4, 2016 |
| Amneal Pharmaceuticals of New York LLC | 3 | tablet | Generic drugs (ANDA) | December 17, 2012 |
| Dr. Reddy's Laboratories Inc. | 3 | tablet, film coated, extended release | Generic drugs (ANDA) | August 9, 2023 |
| Golden State Medical Supply, Inc. | 3 | tablet | Generic drugs (ANDA) | September 11, 2013 |
| Major Pharmaceuticals | 3 | tablet | Generic drugs (ANDA) | June 26, 2019 |
| Metcure Pharmaceuticals, Inc. | 3 | tablet, film coated | Generic drugs (ANDA) | November 14, 2017 |
| Mullan Pharmaceutical Inc. | 3 | tablet, coated | Generic drugs (ANDA) | January 1, 2024 |
| PD-Rx Pharmaceuticals, Inc. | 3 | tablet; tablet, extended release | Generic drugs (ANDA) | May 12, 2016 |
| Par Health USA, LLC | 3 | tablet, film coated, extended release | Generic drugs (ANDA) | July 24, 2026 |
| Proficient Rx LP | 3 | tablet, film coated; tablet, extended release | Generic drugs (ANDA) | March 1, 2013 |
| Puracap Laboratories LLC DBA Blu Pharmaceuticals | 3 | tablet, film coated | Generic drugs (ANDA) | April 1, 2016 |
| Santarus, Inc. | 3 | tablet, film coated, extended release | New drug applications (NDA) | March 20, 2018 |
| Sun Pharmaceutical Industries, Inc. | 3 | tablet, film coated, extended release | Generic drugs (ANDA) | April 6, 2026 |
| Takeda Pharmaceuticals America, Inc. | 3 | tablet, film coated | New drug applications (NDA) | January 25, 2013 |
| Teva Pharmaceuticals USA, Inc. | 3 | tablet, film coated | Generic drugs (ANDA) | October 28, 2005 |
| Unit Dose Solutions, Inc. | 3 | tablet | Generic drugs (ANDA) | June 27, 2026 |
| Advanced Rx of Tennessee, LLC | 2 | tablet, film coated; tablet | Generic drugs (ANDA) | July 10, 2026 |
| AiPing Pharmaceutical, Inc. | 2 | tablet, film coated, extended release | Generic drugs (ANDA) | December 15, 2025 |
| Amneal Pharmaceuticals LLC | 2 | tablet, extended release | Generic drugs (ANDA) | February 26, 2010 |
| Amneal Pharmaceuticals NY LLC | 2 | tablet, extended release | Generic drugs (ANDA) | February 26, 2010 |
| Aphena Pharma Solutions - Tennessee, LLC | 2 | tablet | Generic drugs (ANDA) | September 11, 2013 |
| Apotex Corp. | 2 | tablet, film coated | Generic drugs (ANDA) | May 28, 2026 |
| AvPAK | 2 | tablet, extended release | Generic drugs (ANDA) | May 2, 2022 |
| Glenmark Pharmaceuticals Inc., USA | 2 | tablet, film coated, extended release | Generic drugs (ANDA) | November 25, 2019 |
| Ingenus Pharmaceuticals, LLC | 2 | tablet, extended release | Generic drugs (ANDA) | December 10, 2018 |
| Lifsa Drugs LLC | 2 | tablet | Generic drugs (ANDA) | January 24, 2002 |
| Marlex Pharmaceuticals, Inc. | 2 | tablet, extended release | Generic drugs (ANDA) | September 1, 2026 |
| Method Pharmaceuticals, LLC | 2 | tablet | Generic drugs (ANDA) | February 9, 2026 |
| Oceanside Pharmaceuticals | 2 | tablet, film coated, extended release | Authorized generics (NDA) | March 20, 2018 |
| Padagis Israel Pharmaceuticals Ltd | 2 | tablet, film coated | Authorized generics (NDA) | April 8, 2016 |
| Prasco Laboratories | 2 | tablet, film coated, extended release | Authorized generics (NDA) | January 3, 2024 |
| Qingdao Baheal Pharmaceutical Co., Ltd. | 2 | tablet, film coated, extended release | Generic drugs (ANDA) | December 27, 2018 |
| Redpharm Drug | 2 | tablet, extended release | Generic drugs (ANDA) | October 6, 2023 |
| Sandoz Inc | 2 | tablet, film coated | Generic drugs (ANDA) | May 28, 2026 |
| Solco Healthcare US, LLC | 2 | tablet, extended release | Generic drugs (ANDA) | May 31, 2022 |
| Torrent Pharmaceuticals Limited | 2 | tablet | Generic drugs (ANDA) | September 1, 2025 |
| TruPharma, LLC | 2 | solution | Generic drugs (ANDA) | January 25, 2022 |
| Unichem Pharmaceuticals (USA), Inc. | 2 | tablet, extended release | Generic drugs (ANDA) | August 11, 2021 |
| Unichem Pharmaceuticals (USA), Inc. | 2 | tablet, extended release | Generic drugs (ANDA) | July 17, 2018 |
| Vgyaan Pharmaceuticals LLC | 2 | tablet, extended release | Generic drugs (ANDA) | November 30, 2021 |
| Viona Pharmaceuticals Inc | 2 | tablet, extended release | Generic drugs (ANDA) | March 15, 2019 |
| Bionpharma Inc. | 1 | solution | Generic drugs (ANDA) | July 28, 2025 |
| Calvin Scott & Co., Inc. | 1 | tablet, extended release | Generic drugs (ANDA) | June 8, 2017 |
| Camber Pharmaceuticals, Inc. | 1 | solution | Generic drugs (ANDA) | March 13, 2025 |
| Cardinal Health 107, LLC | 1 | tablet | Generic drugs (ANDA) | June 26, 2019 |
| Golden State Medical Supply, Inc. | 1 | tablet, film coated, extended release | Generic drugs (ANDA) | December 26, 2017 |
| Leading Pharma, LLC | 1 | tablet, extended release | Generic drugs (ANDA) | May 1, 2025 |
| Northwind Health Company, LLC | 1 | tablet | Generic drugs (ANDA) | February 21, 2024 |
| Saptalis Pharmaceuticals, LLC. | 1 | solution | Generic drugs (ANDA) | July 31, 2024 |
Dosage forms
| Dosage form | Products | Share |
|---|---|---|
| Tablet, film coated | 185 | 29.4% |
| Tablet, extended release | 171 | 27.1% |
| Tablet | 167 | 26.5% |
| Tablet, film coated, extended release | 84 | 13.3% |
| Tablet, coated | 16 | 2.5% |
| Solution | 7 | 1.1% |
Updated November 6, 2026. Read from US Food and Drug Administration, National Drug Code Directory (openFDA). CC0 1.0 public domain dedication (openFDA). Counts are products in the FDA National Drug Code Directory on November 6, 2026: 138,262 products in commercial distribution, meaning without a marketing end date in the past. A company is a labeler code; one company can hold several codes, and the directory carries no address. Inclusion in the directory is not FDA approval, and the marketing category says under which kind of application or rule a product is sold. This page uses openFDA data and is not endorsed or certified by FDA. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.